Kit for the Preparation of Technetium Tc99m Mertiatide
Kit for the Preparation of Technetium Tc 99m Mertiatide
Approved
Approval ID
0ad62039-f848-4f3d-b489-2524e6b6b86e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 22, 2021
Manufacturers
FDA
Sun Pharmaceutical Industries, Inc.
DUNS: 139261648
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Betiatide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code45567-0655
Application NumberANDA208994
Product Classification
M
Marketing Category
C73584
G
Generic Name
Betiatide
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 22, 2021
FDA Product Classification
INGREDIENTS (7)
Stannous ChlorideInactive
Quantity: 0.05 mg in 1 1
Code: 1BQV3749L5
Classification: IACT
BetiatideActive
Quantity: 1 mg in 1 1
Code: 9NV2SR34P8
Classification: ACTIB
Lactose MonohydrateInactive
Quantity: 20 mg in 1 1
Code: EWQ57Q8I5X
Classification: IACT
Stannous Chloride AnhydrousInactive
Quantity: 0.2 mg in 1 1
Code: R30H55TN67
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT
Sodium TartrateInactive
Quantity: 40 mg in 1 1
Code: QTO9JB4MDD
Classification: IACT